Mar 27, 2008 8:45 am US/Pacific
FDA Investigating Possible Singulair, Suicide Link
WASHINGTON (AP) ― The Food and Drug Administration said Thursday it is investigating a possible link between Merck's allergy drug Singulair and suicide.
FDA said it is reviewing reports of mood changes, suicidal behavior and suicide in patients who have taken the drug, which was Merck's best-selling product last year.
In the past year Merck has updated the drug's labeling four times to include information on tremors, anxiousness, depression and suicidal behavior reported in some patients.
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http://cbs13.com/national/fda.singular.suicide.2.686104.htmlFDA probes suicide risk in Merck Singulair
Thu Mar 27, 2008 4:05 PM BST
WASHINGTON (Reuters) - U.S. health regulators are probing a possible connection between Merck & Co's Singulair asthma drug and suicidal behavior, the Food and Drug Administration said on Thursday.
The FDA said it is reviewing the issue after receiving reports of mood and behavior changes, suicidal thinking and suicide in patients who took the drug, which is used to treat stuffy nose, sneezing and other allergy symptoms as well as asthma.
The agency did not say how many reports it had received.
While no definite link to the drug has been established, the FDA said it has asked Merck to evaluate its data for more information on the risk. The agency said it expects it to take up to nine months to finish its own review.
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http://today.reuters.co.uk/news/articlenews.aspx?type=healthNews&storyid=2008-03-27T160525Z_01_WBT008653_RTRIDST_0_HEALTH-MERCK-FDA-DC.XML